Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of hydroxychloroquine and how well it works when given together with gemcitabine and docetaxel in treating participants with osteosarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine, docetaxel, and hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered with gemcitabine and docetaxel (G+D) in patients with recurrent/metastatic osteosarcoma. (Phase I) II. To determine whether gemcitabine and docetaxel (G+D) in combination with hydroxychloroquine (HCQ) increases the disease control rate in patients with recurrent/metastatic osteosarcoma at 4 months as compared to historic controls. (Phase II) SECONDARY OBJECTIVES: I. To determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) of the combination of G + D + HCQ in patients with recurrent/metastatic osteosarcoma. II. To estimate the event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) for patients with recurrent/metastatic osteosarcoma treated with G+D+HCQ. III. To estimate the toxicity rates of oral HCQ when administered in conjunction with G+D. IV. To investigate the pharmacokinetics (PK) of the combination in patients with recurrent/metastatic osteosarcoma. EXPLORATORY OBJECTIVES: I. To describe the metabolic response rates of G + D + HCQ in patients recurrent/metastatic measurable osteosarcoma by positron emission tomography (PET)/computed tomography (CT) at 6 weeks. II. To assess pre-/post-treatment changes in autophagy biomarkers (autophagic vesicles, LC3B puncta, p62, and HMGB1), HSP27, and pHSP27 expression in tumor samples at baseline and during cycle #2 of treatment with G + D + HCQ. III. To assess the relationship between probability of response and/or disease control and tumor HSP27, pHSP27, ALDH1A1, and HLTF expression. IV. To complete functional proteomic profiling of autophagic and apoptotic pathways on tumor samples by RPPA and correlate findings with the probability response and disease control. OUTLINE: This is a phase I, dose-escalation study of hydroxychloroquine followed by a phase II study. Participants receive hydroxychloroquine orally (PO) once daily (QD) or twice daily (BID) on days 1-21, gemcitabine intravenously (IV) over 90 minutes on days 1 and 8, and docetaxel IV over 1 hours on day 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 1 year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03598595
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 28, 2019
Completion date September 13, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT00093821 - Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors Phase 1
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT01553539 - Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery Phase 2
Completed NCT00091182 - Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment Phase 2
Completed NCT00004078 - Irinotecan in Treating Children With Refractory Solid Tumors Phase 2
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Active, not recruiting NCT04284774 - Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2
Active, not recruiting NCT03213678 - Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT04668300 - Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma Phase 2
Completed NCT02470091 - Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma Phase 2
Completed NCT01016015 - Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma Phase 2
Completed NCT01807052 - Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas N/A
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT03213665 - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Not yet recruiting NCT03205644 - VX15/2503 in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04320888 - Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Completed NCT00030667 - Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood Phase 2